FDA Device recall Z-2770-2016

Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets…

FDA Device
Class II
terminated
Published 2016-09-21

On 2016-09-21 the FDA classified a Class II recall of Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets… by Sysmex America, citing there is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IP….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2770-2016
Classification	Class II
Status	terminated
Initiated	2016-07-01
Published	2016-09-21
Last updated	2026-09-13 11:54 UTC
Company	Sysmex America
Distribution	US

Product

Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers

Reason

There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F results displayed a "PLT Abn Scattergram" message with asterisks beside the results indicating the data is unreliable. In rare instances, platelet flags may be absent. The PLT-I counts are unaffected. The PLT-F is a reflex test used to confirm PLT-I results due to flagging or low values. As such, the likely impact to patient results is low. Affected results display a discrepancy between the PLT-I and PLT-F, with lower than expected PLT-F results that do not match the patient's clinical picture.

Identifiers

code_info	Lot number A5053, Expiration date 12/21/2016 Lot number A5054, Expiration date 12/21/2016 Lot number A5041, Expiratio… Lot number A5053, Expiration date 12/21/2016 Lot number A5054, Expiration date 12/21/2016 Lot number A5041, Expiration date 9/2/2016 Lot number A5042, Expiration date 9/2/2016 Lot number A5044, Expiration date 10/2/2016 Lot number A5046, Expiration date 11/9/2016 Lot number A5047, Expiration date 11/17/2016 Lot number A5048, Expiration date 11/17/2016 Lot number A5049, Expiration date 11/26/2016 Lot number A5050, Expiration date 11/26/2016 Lot number A5055, Expiration date 12/24/2016

code_info

Lot number A5053, Expiration date 12/21/2016 Lot number A5054, Expiration date 12/21/2016 Lot number A5041, Expiratio…

Lot number A5053, Expiration date 12/21/2016 Lot number A5054, Expiration date 12/21/2016 Lot number A5041, Expiration date 9/2/2016 Lot number A5042, Expiration date 9/2/2016 Lot number A5044, Expiration date 10/2/2016 Lot number A5046, Expiration date 11/9/2016 Lot number A5047, Expiration date 11/17/2016 Lot number A5048, Expiration date 11/17/2016 Lot number A5049, Expiration date 11/26/2016 Lot number A5050, Expiration date 11/26/2016 Lot number A5055, Expiration date 12/24/2016

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-2770-2016%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.