Recall Z-1263-2020 ยท KHP Acid, Lactic, Enzymatic Method
Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
| Date | Feb 18, 2020 (initiated Jan 15, 2020) |
| Status | Terminated |
| Reason | The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CL |
| Root cause | No Marketing Application |
| Action | On 1/15/2020, the firm notified customers of the product recall via letters, customer emails, follow-up phone calls/visits by sales representatives, and a website posting at www.pointofcare.abbott. Customers were instructed to do the following: Facilities using the i-STAT BLUE CHEM8+ cartridges in CLIA waived settings should transition to alternate CLIA waived testing methods or engage a reference laboratory for the tests your facility requires. Facilities should discontinue use of the i-STAT BLUE CHEM8+ and CG4+ cartridges with capillary samples. Facilities should use an alternate method, |
| Quantity | 99,850 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.