Reported Jul 14, 2021 · Ongoing
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
Sentinel CH SpA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sentinel CH SpA · Via Robert Koch 2 · Milan · N/A
Is this the product you have?
- ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
- Lot codes and dates
- Lot Numbers/ Exp
- Date
80516 31/07/202180635 30/09/202190092 31/12/202190599 31/12/202100118 31/12/202100360 31/12/202100610 31/12/202100702 31/12/2021
- UDI01)08058056681775( 17)210731( 10)80516(240) 1667001 {01)08058056681775( 17)210930(10)80635{240) 1667001 {01)08058056681775( 17)211231(10)90092(240) 1667001 {01)08058056681775( 17)211231(10)90599{240) 1667001 {01)08058056681775( 17)211231( 10)00118(240) 1667001 {01)08058056681775( 17)211231(10)00360(240) 1667001 {01)08058056681775( 17)211231( 10)00610(240) 1667001 {01)08058056681775( 17)211231(10)00702{240) 1667001
- Amount recalled
- 1898 kits
Where it was sold
- Nationwide
Why it was recalled
Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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