BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Reported: May 17, 2023 Initiated: February 28, 2023 #Z-1572-2023
Product Description
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
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.
Details
- Recalling Firm
- Bio-Rad Laboratories, Inc.
- Units Affected
- 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.
- Location
- Redmond, WA
Frequently Asked Questions
What product was recalled? ▼
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack. Recalled by Bio-Rad Laboratories, Inc.. Units affected: 932 Reagent Packs.
Why was this product recalled? ▼
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2023. Severity: Moderate. Recall number: Z-1572-2023.
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