Z-1971-2020Class II

Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS)...

Name: Z-1971-2020 Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS)...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2020-03-31
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2020-03-31 / Terminated / root cause: manufacturing process

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage... on 2020-03-31. FDA classified it as Class II and gives the reason as "False positive reaction on the reagent". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1971-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-31
Posted: 2020-05-13
Terminated: 2021-04-27
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and be equipped with appropriate software (such as BD CellQuest, BD CellQuest Pro, BD FACSDiva, or BD FACSCanto clinical software) for data acquisition and analysis.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: False positive reaction on the reagent.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: URGENT MEDICAL DEVICE RECALL letter was sent to the customers on 03/31/2020 via FedEx, emailed or faxed. The acknowledgement form included with the letter that is mailed, faxed, emailed, back to BD will be reconciled with the customer list.
Quantity in commerce: 1473 vials.
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI and Puerto Rico. The countries of Argentina, Australia, Belgium, Brazil, Canada, China, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan and Vietnam.
Product codes and lots: Analyte specific reagent - BD CD45 APC-H7. REF/ Lot Number: 641408/9057729; 541417/9056804; 641399/9065949

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1971-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1971-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-13

Product code MVU

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)