Z-2770-2016Class II

Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample...

Name: Z-2770-2016 Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample...
Creator: Sysmex America Inc
Published: 2016-07-01
License: https://open.fda.gov/license/

Sysmex America, Inc. / initiated 2016-07-01 / Terminated

FDA source

Sysmex America Inc began a recall of 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... on 2016-07-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2770-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-09-09
Terminated: 2017-02-10
Recalling firm: Sysmex America, Inc.
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
Product code: KQC Stains, Hematology
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: Sysmex sent a Product Notification Letter dated August 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. . Customers were instructed to cease use and discard the affected lots, and reply to Sysmex America, Inc. using the provided fax-back form. An updated Product Notification (Attachment 1) was mailed to all XN-Series customers on August 12, 2016 informing them of the additional recalled lots. This notification included the phone number for the Technical Assistance Center at 1-888-879-7639 in the U.S., and 1-888-679-7639 in Canada.
Quantity in commerce: 3868 units
Distribution: Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2770-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2770-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09

Product code KQC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)