Z-0927-2013Class II

ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement...

Name: Z-0927-2013 ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement...
Creator: Innominata Dba Genbio
Published: 2013-02-11
License: https://open.fda.gov/license/

Genbio / initiated 2013-02-11 / Terminated / root cause: manufacturing process

FDA source

Innominata Dba Genbio began a recall of ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532... on 2013-02-11. FDA classified it as Class II and gives the reason as "Multiple incidents of low-reacting assay plates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0927-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-11
Posted: 2013-03-08
Terminated: 2013-08-27
Recalling firm: Genbio
Product: 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 code: LSR Reagent, Borrelia Serological Reagent
Reason for recall: Multiple incidents of low-reacting assay plates.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Innominata dba GenBio, sent an "Urgent Product Correction" letter dated February 11, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the listed questions to determine sites risk and take the appropriate actions. For questions regarding this issue, customers may contact Bio-Rad Technical Support at : 1-800-224-6723, option #2, and then option #3 for assistance.
Quantity in commerce: 195
Distribution: Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0927-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0927-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-08

Product code LSR

K911590Class IIImmunowell Borrelia (Lyme)testGeneral Biometrics, Inc. / cleared 1991-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)