Recall Z-1572-2023 ยท MID System, Test, Anticardiolipin Immunological
Bio-Rad Laboratories, Inc.
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
| Date | May 10, 2023 (initiated Feb 28, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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 t |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130528 | BIOPLEX 2200 APLS IGM Bio-Rad Laboratories, Oct 21, 2013 |