Biochemical Diagnostics Recalls hCG Control Kits Due to Labeling Discrepancies
Biochemical Diagnostics Inc. is recalling CONSULT hCG Controls Kits because storage temperature instructions on the kit labels do not match the vial labels and package insert.
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 minor labeling error regarding storage temperatures, with no reported injuries or illnesses.
Plain-English summary
Biochemical Diagnostics Inc. is voluntarily recalling the CONSULT diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011. This in vitro diagnostic (IVD) product is intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
The recall was initiated because the storage temperatures listed on the kit labels are discrepant when compared with the individual vial labels and the package insert. This labeling inconsistency could lead to improper storage of the control materials.
The affected lots are KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11), and KN177 (exp. 2018-02). A total of 4,473 kits were distributed nationwide in the United States. Users should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
- Manufacturer
- Biochemical Diagnostics Inc
- Hazard
- Affected units
- 4,473
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 (3)
- Lot/Codes: KN165 (exp. 2017-09)
- KN169 (exp. 2017-10)
- KN171 (exp. 2017-11) and KN177 (exp. 2018-02)
Distribution
Distributed nationwide across the United States.
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