ACE Control Set stability claim failure requires updated handling instructions
Sentinel CH SpA is recalling ACE Control Set diagnostic control kits due to stability claims after reconstitution that do not meet specified requirements. Updated handling instructions have been provided to affected users.
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 2/5 (Moderate).
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: FDA Class III classification with no reported illnesses, injuries, or adverse events. The issue is a technical failure of stability claims in an in vitro diagnostic control product, with updated instructions provided by the manufacturer to mitigate risk.
Plain-English summary
Sentinel CH SpA is recalling the ACE Control Set (REF 1667001), an in vitro diagnostic control kit used for quantitative determination of Angiotensin Converting Enzyme (ACE). The recall is due to stability claims made after reconstitution from lyophilized (freeze-dried) to liquid form that do not meet the product's specified requirements.
The recall affects approximately 1,898 kits distributed worldwide, including to the United States and 28 countries such as Canada, Australia, and multiple European nations. Eight specific lot numbers are affected, with expiration dates ranging from July 2021 to December 2021.
Sentinel CH SpA has issued new handling instructions for the product to affected end users. Healthcare providers and laboratories using affected kits should implement the updated instructions provided by the manufacturer.
The recalled product
- Product
- ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
- Manufacturer
- Sentinel CH SpA
- Affected units
- 1,898
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 Numbers/ Exp. Date: 80516 31/07/2021
- 80635 30/09/2021
- 90092 31/12/2021
- 90599 31/12/2021
- 00118 31/12/2021
- 00360 31/12/2021
- 00610 31/12/2021
Distribution
Distributed nationwide across the United States.
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