Ortho-Clinical Diagnostics Recalls VITROS Intact PTH Reagent Packs
Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to a positive bias of up to 20% and an incorrectly set reference interval.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a defect in measurement accuracy and reference intervals without reporting any specific patient injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 7,027 units of VITROS Immunodiagnostic Products Intact PTH Reagent Packs. The affected products include Reagent Packs (UPN 10758750006287) and Calibrators (UPN 10758750006250) used for the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma. The recall covers specific lots with expiry dates ranging from October 2016 to April 2017. The products were distributed nationwide and in various countries including Australia, Brazil, Canada, China, and Germany.
The recall was initiated because the device exhibits a positive bias of up to 20% relative to the currently marketed Roche device. Additionally, the manufacturer determined that the cleared reference interval was not set optimally at the product's launch in 2010. Specifically, the upper limit in the Instructions for Use (IFU) of 53.5 pg/mL is too low and should be closer to 80 pg/mL. The firm is currently submitting data to support the revised reference interval in a new 510(k) submission and will update the IFU once the submission is cleared.
Healthcare facilities and laboratories using these reagent packs should stop using the affected lots and contact Ortho-Clinical Diagnostics for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (E
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Affected units
- 7,027
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 (7)
- Lot / Expiry date: 1) 0700 (18 Oct 2016)
- 0710 (14 Nov 2016)
- 0748 (16 Feb 2017
- 0758 (06 Mar 2017)
- 2) 0728 (12 Dec 2016)
- 0738 (02 Jan 2017)
- 0768 (10 Apr 2017)
Distribution
Distributed nationwide across the United States.
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