Remel recalls

Remel appears in 86 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium…
  FDA Device · Class II · 2017-05-03 · Remel
  Reason: Confirmed complaint of surface contamination of Listeria monocytogenes.
• Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033
  FDA Device · Class II · 2017-03-15 · Remel
  Reason: Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
• Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd
  FDA Device · Class II · 2016-06-15 · Remel
  Reason: Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
• Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge
  FDA Device · Class II · 2015-12-23 · Remel
  Reason: Antibiotic concentration may be insufficient which may result in incorrect test results.
• PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap
  FDA Device · Class II · 2015-08-19 · Remel
  Reason: A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
• PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit
  FDA Device · Class II · 2015-08-19 · Remel
  Reason: A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
• VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc
  FDA Device · Class II · 2015-07-01 · Remel
  Reason: Use of the recalled product may result in false positive reports.
• VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc
  FDA Device · Class II · 2015-07-01 · Remel
  Reason: Use of the recalled product may result in false positive reports.
• Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates)
  FDA Device · Class II · 2015-06-17 · Remel
  Reason: Product may be contaminated with Listeria monocytogenes.
• Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials
  FDA Device · Class II · 2015-03-11 · Remel
  Reason: Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
• Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials
  FDA Device · Class II · 2014-12-17 · Remel
  Reason: Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
• Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box
  FDA Device · Class II · 2014-12-03 · Remel
  Reason: A reagent within the test may return false negative results.
• Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box
  FDA Device · Class II · 2014-12-03 · Remel
  Reason: A reagent within the test may return false negative results.
• Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg
  FDA Device · Class II · 2014-12-03 · Remel
  Reason: The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
• Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg
  FDA Device · Class II · 2014-11-19 · Remel
  Reason: Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
• Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel…
  FDA Device · Class II · 2014-07-23 · Remel
  Reason: Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
• Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box
  FDA Device · Class II · 2014-04-30 · Remel
  Reason: A reagent contained within the product may return false negative results.
• Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box
  FDA Device · Class II · 2014-04-30 · Remel
  Reason: A reagent contained within the product may return false negative results.
• Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, H…
  FDA Device · Class II · 2014-03-26 · Remel
  Reason: Some of the discs may not be impregnated with the antibiotic.
• Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized
  FDA Device · Class II · 2014-03-05 · Remel
  Reason: The product may contain high levels of microbial contamination
• Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack
  FDA Device · Class II · 2014-01-29 · Remel
  Reason: Cartridges may contain individual discs which were not impregnated with antibiotic.
• Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack
  FDA Device · Class II · 2014-01-29 · Remel
  Reason: Cartridges may contain individual discs which were not impregnated with antibiotic.
• Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack
  FDA Device · Class II · 2014-01-29 · Remel
  Reason: Cartridges may contain individual discs which were not impregnated with antibiotic.
• Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack
  FDA Device · Class II · 2014-01-29 · Remel
  Reason: Cartridges may contain individual discs which were not impregnated with antibiotic.
• Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 5…
  FDA Device · Class II · 2014-01-22 · Remel
  Reason: Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
• Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a co…
  FDA Device · Class II · 2013-12-25 · Remel
  Reason: The product may give weak or false negative test results.
• Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box
  FDA Device · Class III · 2013-12-25 · Remel
  Reason: Boxes labeled as CIP5 may contain cartridges of AMP5.
• Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box
  FDA Device · Class II · 2013-12-25 · Remel
  Reason: The product may give weak or false negative test results.
• remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of…
  FDA Device · Class II · 2013-12-25 · Remel
  Reason: The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
• Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack
  FDA Device · Class III · 2013-09-04 · Remel
  Reason: Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
• Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Con…
  FDA Device · Class III · 2013-08-21 · Remel
  Reason: Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
• The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionell…
  FDA Device · Class II · 2013-02-20 · Remel
  Reason: The product may contain low level microbial contamination which could result in incorrect results.
• Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650
  FDA Device · Class II · 2013-02-20 · Remel
  Reason: The firm is recalling the products due to a potential for false negative test results.
• Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box
  FDA Device · Class II · 2013-02-20 · Remel
  Reason: The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
• Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640
  FDA Device · Class II · 2013-02-20 · Remel
  Reason: The firm is recalling the products due to a potential for false negative test results.
• Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel &am…
  FDA Device · Class II · 2013-02-13 · Remel
  Reason: The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a…