FDAFDA · Food and drugs·Recall number Z-0927-2013
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
Published March 20, 2013 · Recall initiated: February 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Multiple incidents of low-reacting assay plates.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Innominata Dba Genbio
- Distributor
- Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
- Lot
- Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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