Z-2445-2012Class III

Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests

Name: Z-2445-2012 Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests
Creator: Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Published: 2012-05-29
License: https://open.fda.gov/license/

Trinity Biotech USA / initiated 2012-05-29 / Terminated / root cause: manufacturing process

FDA source

Clark Laboratories, Inc. (dba,Trinity Biotech USA) began a recall of Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and... on 2012-05-29. FDA classified it as Class III and gives the reason as "The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range". 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-2445-2012
Classification: Class III
Status: Terminated
Initiated: 2012-05-29
Posted: 2012-09-24
Terminated: 2016-05-24
Recalling firm: Trinity Biotech USA
Product: Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Product code: GQX Antiserum, Cf, Varicella-Zoster
Reason for recall: The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Trinity Biotech sent a "PRODUCT RECALL LETTER" dated May 29, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Fax Back Form was included in the letter for customers to complete and return via fax to (716) 488-1990. Customers were instructed to discard any of the affected product. Contact the Trinity Biotech Help Desk at 800-325-3424, option 2 for questions regarding this recall.
Quantity in commerce: 810 kits
Distribution: Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
Product codes and lots: Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2445-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2445-2012	Class III	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-24

Product code GQX

K883427Class IIVirgo(r) Vzv-Igg ElisaElectro-Nucleonics, Inc. / cleared 1989-03-10

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)