FDA Device recall Z-0605-2018
Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods…
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods… by Beckman Coulter, citing unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0605-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-24 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV, WY |
Product
Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Phosphorus (PHOS), Iron, Lactate, Magnesium (MG), Total Protein (TP), Triglyceride (TRIG), Unbound Iron Binding Capacity (UIBC), Urea Nitrogen (BUN), and Uric Acid. Only lots 6101K51 and 6101K61 were subject to recall.
Reason
Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. QC failures could occur if incorrect pairs of calibrators are used.
Identifiers
| code_info | Lots # 6101K51 and 6101K61 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0605-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.