Sentinel CH recalls Multigent Lithium Reagent Kits (8L25-30, 08P5320) that may cause falsely elevated lithium test results due to carryover from LDH reagent. Consumers should check product labels for lot numbers.
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results
Sentinel CH is recalling specific Multigent Lithium Reagent Kits that could cause false high lithium test results when used with certain analyzers. This may lead to incorrect medical diagnoses if not addressed.
The reagent kits may cause carryover from the Lithium Dehydrogenase (LDH) reagent, leading to falsely elevated lithium levels in patient tests. This could result in incorrect medical decisions if the false high readings are not recognized.
Patients using these reagent kits for lithium testing in blood tests may be at risk of incorrect results. Healthcare providers using the kits with ARCHITECT or Alinity c analyzers are most affected.
Check product labels for lot numbers: 71175Y600, 80362Y600, 80201Y600, 80533Y600, 80463Y600, 80424Y600, or 80605Y600. These kits are intended for lithium testing with ARCHITECT or Alinity c analyzers.
Look for lot numbers 71175Y600, 80362Y600, 80201Y600, 80533Y600, 80463Y600, 80424Y600, or 80605Y600 on the reagent kit packaging.
The reagent kit may cause falsely elevated lithium test results if carryover from the LDH reagent occurs, potentially leading to incorrect medical diagnoses.
Check the product label for lot numbers: 71175Y600, 80362Y600, 80201Y600, 80533Y600, 80463Y600, 80424Y600, or 80605Y600.
No action is needed if you do not have the recalled lot numbers. Only check labels to confirm if your kit is affected.
We’ve drafted a message you can send Sentinel CH to request your refund or repair — edit it as you like.
Subject: Recall Z-2551-2019 — Sentinel CH Sentinel CH Hello, I own a Sentinel CH that is covered by recall Z-2551-2019 from Sentinel CH. 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.