Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Stem – Kit Reagents 50 tests [REF: IM3630; Lot Number: 200326, 200327, 200328, 200329, 200330, 200332; Expiry Date: 14 Dec 2021, 16 Feb 2022, 17 May 2022]
The manufacturer discovered that the recommended specimen storage temperature and prepared sample stability for some specimen types listed are erroneously indicated in the Stem-Kit Reagents Instructions for Use (IFU) (PN B60229 Rev. AH) and stemCXP System Guide (PN 627260 Rev. BC), which may lead to erroneous results. Inappropriate storage of samples may lead to degradation of CD34+ cells which could potentially lead to an additional or unnecessary stem cell collection .It may also delay or cause missing opportunity of peripheral blood stem cell collection necessary to proceed to cancer chemotherapy. For details, please refer to the device recall letter issued by manufacturer to its customer.
The manufacturer will update the Stem-Kit Reagents IFU (PN B60229) and stemCXP System Guide (PN 627260) to indicate the revised storage conditions. Affected users should follow the revised storage conditions listed on the customer letter issued by the manufacturer.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Sep 2021