Recall Z-2139-2020 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer Medical ApS
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
| Date | Nov 21, 2019 |
| Status | Terminated |
| Reason | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors. |
| Root cause | Nonconforming Material/Component |
| Action | Two Urgent Medical Device Recall Letters were sent to customers at the user level via email followed by a hard copy letter sent FedEx 2nd day with tracking and proof of delivery. The first letter, dated 11-21-2019, was intended for customers not utilizing the analyzer for measuring blood samples from newborn babies of up to four weeks of age. The letter informed customers of biased results for tbil, that the bias increases with tHb concentration, and that the increase is not linear. Customers were informed of the potential risks to patients, and were requested to complete the Recall Response F |
| Quantity | 1233 units |
| Distribution | Worldwide distribution - US Nationwide. Also distributed OUS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092686 | ABL90 FLEX SERIES Radiometer Medical Aps, Aug 6, 2010 |