Z-1572-2023Class II

BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

Name: Z-1572-2023 BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Creator: Bio-Rad Laboratories, Inc.
Published: 2023-02-28
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2023-02-28 / Open, Classified / root cause: packaging

FDA source

Bio-Rad Laboratories, Inc. began a recall of BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack on 2023-02-28. FDA classified it as Class II and gives the reason as "APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1572-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-28
Posted: 2023-05-10
Recalling firm: Bio-Rad Laboratories Inc.
Product: BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Product code: MID System, Test, Anticardiolipin Immunological
Reason for recall: APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On February 28, 2023, Bio-Rad Laboratories issued an "Urgent: Medical Device Recall" letter to affected consignees. In addition, to informing consignees about the recall, they ask consignees to take the following actions: We are requesting that customers perform quality control using the BioPlex APLS IgM Control Set (Catalog No. 663-2030, UDI GTIN 00847865000642) with each reagent pack ( single pack validation ) of BioPlex 2200 APLS IgM Reagent Pack, Lot No. 301538, until replacement product is provided. If QC fails (controls below or above the acceptable range), please discontinue use of the reagent pack and dispose of it according to local waste management procedures. If the control values are within the acceptable range, the reagent pack may be used and patient results may be released. If you have distributed or transferred this product to any other Bio-Rad customers, or to any other laboratories from your site, please notify those customers of this field action. Please complete the attached Customer Response Form and return it to your local Bio-Rad Technical Support so they can assist you with obtaining replacement reagent packs as needed.
Quantity in commerce: 932 Reagent Packs
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.
Product codes and lots: Lot Code: 301538; UDI-DI: (00)847865000666

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1572-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1572-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-10

Product code MID

K130528Class IIBioplex 2200 Apls IgmBio-Rad Laboratories / cleared 2013-10-21

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)