BioPlex 2200 recall
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Why was BioPlex 2200 recalled?
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: 301538; UDI-DI: (00)847865000666
- Product
- BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
- Recalling firm
- Bio-Rad Laboratories, Inc.
- 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.
- Recall date
- May 17, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)