i-STAT cTnI cartridge
This recall has been terminated (originally issued October 16, 2019).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- October 16, 2019
- Terminated
- May 4, 2020
- Recall Number
- Z-0761-2020
- Quantity
- 3,465,875
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
Distribution
US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY
Lot / Code Info
List Number: 06P23-25 UDI: (01)00054749001986
Root Cause
Device Design
Action Taken
On October 16, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail. It explains Abbott Point of Care has made the decision to transition U.S. customers using the i-STAT cTnI blue cartridge, list number 06P23-25, to the i-STAT cTnI white cartridge, list number 03P90-25, beginning in November 2019. The i-STAT cTnI blue cartridge, list number 06P23-25, will be discontinued for sale in the United States as of January 1, 2020. It further explains to customers while the i-STAT cTnI blue cartridges can continue to be used for patient testing, APOC recommends that all users of the i-STAT System be informed of the possibility of a higher than expected number of quality check codes while using the i-STAT cTnI blue cartridge and maintain a validated alternate backup method until the i-STAT cTnI white cartridges are received. Your Abbott Point of Care representative will contact you to discuss the details and timing of this transition for your facility. If your facility repeatedly observes the i-STAT cTnI blue cartridges from a single lot generating a higher than expected number of QCCs, please contact APOC Technical Services for support and to report the information. If you have forwarded any i-STAT cTnI blue cartridges to another facility, please provide a copy of this letter to them. ADDITIONAL INFORMATION If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 1-866-324-8114, or via email at apoc_cTnIproductinfo@abbott.com or contact your Abbott Point of Care support services representative. We appreciate your understanding in this matter and thank you for your continued support of Abbott and Abbott products.