Mechatronics USA recalls RR Mechat: Control Level A ESR Control4.6 ml QRR049002 materials due to incorrect labeling causing false out-of-range flags in ESR instruments. Affected units have specific lot numbers and expiration dates.
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.
Mechatronics USA is recalling RR Mechatronics Control Level A ESR quality control materials because some vials are incorrectly labeled. This can cause ESR instruments to flag results as out of range when they are not. Affected units may need to be replaced to ensure accurate test results.
The vials are incorrectly labeled, meaning the instrument may flag results as out of range when they are actually within acceptable limits. This could lead to false positive test results for ESR, potentially affecting medical decisions.
Users of ESR (erythrocyte sedimentation rate) blood tests who own the specific lot numbers listed in the recall. Those using the materials for medical testing are most at risk of inaccurate results.
Check for the lot number QCAB6AAA28 on the vial with expiration date 24-02-2022. The product code is A0026578 and the UDI is (01)08719189137125(17)240222(10)QCAB6AAA28.
Look for the lot number QCAB6AAA28 and expiration date 24-02-2022 on the vial.
The vials are incorrectly labeled as QRR049002 when they should be QRR049001, causing ESR instruments to flag results as out of range.
Check the vial label for lot number QCAB6AAA28 and expiration date 24-02-2022. If it matches, contact Mechatronics USA for a replacement.
The product is safe to use if it has the correct labeling. Incorrectly labeled vials may cause false out-of-range flags in ESR instruments.
We’ve drafted a message you can send Mechatronics USA to request your refund or repair — edit it as you like.
Subject: Recall Z-1695-2023 — Mechatronics USA Mechatronics USA Hello, I own a Mechatronics USA that is covered by recall Z-1695-2023 from Mechatronics USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
