DRG International recalls C-Peptide ELISA test kits where low standard optical density may cause invalid runs and delayed patient results. Affected kits have specific catalog numbers and expiration dates.
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
DRG International recalls certain C-Peptide ELISA test kits that may produce invalid results if the standard optical density is too low. This could delay patient results and requires immediate attention from healthcare providers using these kits.
The test kits may produce invalid results if the standard optical density is below 0.6 ODmax. This can lead to delayed patient results but does not cause injury or damage to the user.
Healthcare providers using DRG's C-Peptide ELISA test kits with catalog numbers EIA-1293 (lots 20K061, 20K071, 20K081) are most at risk. These kits were sold with specific expiration dates.
Check for catalog number EIA-1293 with lot numbers 20K061 (expires June 30, 2022), 20K071 (expires July 31, 2022), or 20K081 (expires August 31, 2022).
Verify the expiration date on the kit label matches the dates listed: June 30, 2022 for lot 20K061; July 31, 2022 for lot 20K071; August 31, 2022 for lot 20K081.
Low standard optical density (< 0.6 ODmax) may cause invalid runs and delayed patient results.
Kits with catalog number EIA-1293 and lot numbers 20K061, 20K071, or 20K081.
No action is required beyond checking the expiration date and ensuring the kit is used within its valid period.
We’ve drafted a message you can send DRG International to request your refund or repair — edit it as you like.
Subject: Recall Z-0896-2022 — DRG International DRG International Hello, I own a DRG International that is covered by recall Z-0896-2022 from DRG International. 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.
