Ortho-Clinical Diagnostics Recalls VITROS Total Beta-hCG II Reagent Packs
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Total Beta-hCG II Reagent Packs and Calibrators because they may generate false positive results for hCG levels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may produce inaccurate diagnostic results (false positives), which poses a risk of harm through misdiagnosis or unnecessary treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 14,780 pieces of VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Packs and Calibrators. The affected products are used for the quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma. The recall covers specific lot numbers with expiry dates ranging from June 2016 to September 2016, distributed nationwide.
The recall was initiated because testing revealed that certain lots of the VITROS Systems generated results within the measuring range for samples known to not contain measurable hCG. Specifically, the system reported results up to approximately 7.40 mIU/mL for patient samples that should have been below the assay's measuring range of less than 2.39 mIU/mL. This indicates a potential for false positive results in patients who do not have measurable hCG levels.
Healthcare facilities and laboratories that possess these specific lots of reagent packs and calibrators should stop using them immediately. Users should contact Ortho-Clinical Diagnostics for instructions on how to return the affected products for credit or replacement.
The recalled product
- Product
- 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For…
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 14,780
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 (8)
- Product Codes: 6802220
- 6802221
- Affected Lot Numbers: 1410
- 1420
- 1430 (With Expiry Date 17-Jun-2016)
- Lot Number: 1440 (With Expiry Date 15-Aug-2016
- Lot Numbers: 1450
- 1460
Distribution
Distributed nationwide across the United States.
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