Trinity Biotech Captia VZV IgG Kits Recalled for Positive Control Issues
Clark Laboratories is recalling 810 Captia VZV IgG kits because the positive control ran high out of its assigned range.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a technical deviation in the positive control range rather than a direct physical hazard.
Plain-English summary
Clark Laboratories, Inc. (dba Trinity Biotech USA) is recalling 810 kits of the Captia Varicella-Zoster Virus (VZV) IgG. The affected product codes are 2325600 (96 Tests) and 2325601 (480 tests). The specific lot codes involved are 2325600-566, 2325601-566, 2325600-567, 2325601-567, and 2325600-568.
The recall was initiated because the Positive Control for the kit was reported as running high out of its assigned ISR (Interpretive Standard Range). This is an in vitro diagnostic product intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
The products were distributed nationwide, including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, and TX. Users should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- 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.
- Hazard
- Affected units
- 810
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Kit lot codes: 2325600-566
- 2325601-566
- 2325600-567
- 2325601-567
- 2325600-568
Distribution
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