Z-1096-2022Class II

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

Name: Z-1096-2022 BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Creator: Bio-Rad Laboratories, Inc.
Published: 2022-04-14
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2022-04-14 / Open, Classified

FDA source

Bio-Rad Laboratories, Inc. began a recall of BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack on 2022-04-14. FDA classified it as Class II and gives the reason as "Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1096-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-14
Posted: 2022-05-16
Recalling firm: Bio-Rad Laboratories Inc.
Product: BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Reason for recall: Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
FDA root cause: Under Investigation by firm
Action: On 04/14/2022, Bio-Rad Laboratories sent an "URGENT: Medical Device Recall" letter via FedEx to customers informing them that Bio-Rad has identified a performance concern for the CMV IgM analyte in the BioPlex 2200 ToRC IgM kit lot 301388. The CMV IgM analyte has demonstrated variable elevated background depending on the handling of the reagent pack. Agitation of the conjugate within the reagent pack has demonstrated a potential for both false negative and false positive results for the CMV IgM assay. QC failures may prevent the release of incorrect results; however, QC may not detect all occurrences of the issue. Customers are instructed to immediately discontinue use and to dispose of any unused product of Lot No. 301388. If the affected lot has been further distributed or transferred the product to other Bio-Rad customers, or labs, these customer/labs should be notified of this field action/recall. For questions or further assistance, contact local Bio-Rad Technical Support.
Quantity in commerce: 348 units
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy.
Product codes and lots: Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1096-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1096-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-16

Product code LIP

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)