CooperSurgical recalls LifeGlobal Fast Freeze Thawing Kit Model GFT5-055 due to Spanish instructions incorrectly stating 5-minute air thaw instead of 5 seconds. This could lead to improper freezing.
There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.
CooperSurgical is recalling LifeGlobal Fast Freeze Thawing Kit Model GFT5-055 because the Spanish version of the user manual says to air thaw for 5 minutes instead of the correct 5 seconds. This error could cause improper freezing of samples.
The Spanish version of the user manual incorrectly states that blastocytes should air thaw for 5 minutes instead of the correct 5 seconds. This error could lead to improper freezing of samples, potentially causing them to become damaged or ineffective.
Users of the LifeGlobal Fast Freeze Thawing Kit Model GFT5-055 who follow the Spanish instructions may be affected. Laboratory staff handling biological samples are most at risk.
Check for the model number GFT5-055 on the kit. The kit was sold with specific lot numbers and UDI codes listed in the recall notice.
Check if the Spanish version of the user manual says to air thaw for 5 minutes instead of 5 seconds.
The Spanish version of the user manual incorrectly states that blastocytes should air thaw for 5 minutes instead of the correct 5 seconds.
The model number is GFT5-055.
The recall notice does not mention a fix or remedy.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1421-2022 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-1421-2022 from CooperSurgical. 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.
