Innominata Dba Genbio: Medical Device Recall in 2013 - (Recall #: Z-0927-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 11, 2013

Date Posted: March 20, 2013

Recall Number: Z-0927-2013

Event ID: 64348

Reason for Recall:

Multiple incidents of low-reacting assay plates.

Status: Terminated

Product Quantity: 195

Code Information:

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

Distribution Pattern:

Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated