Reported Jun 14, 2023 · Ongoing
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor…
Mechatronics USA
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: Mechatronics USA · 20 Altieri Way Unit 4 · Warwick, RI · 02886-1761
Is this the product you have?
- RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures
- Product CodeA0026578
- Lot codes and dates
- UDI(01)08719189137125(17)240222(10)QCAB6AAA28 Lot Number/Exp
- DateQCAB6AAA28 24-02-2022
- Amount recalled
- 10752 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- OH
Why it was recalled
QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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