Recall Z-1320-06 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.
| Date | Aug 3, 2006 (initiated Jun 9, 2005) |
| Status | Terminated |
| Reason | The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the pO2 sample results. |
| Root cause | Other |
| Action | The firm issued a letter to their customers dated 6/9/2005. The letter reports the defect with the ABL5 Capillary Adapters and informs the customers that Radiometer reps will be replacing all of the customers'' ABL5 adaptors ASAP. The letter is accompanied by a single bag of new adaptors for the customers'' ''immediate needs'' and also provides a faxed response form which the customer can use to request additional adapters as required. In addition, should the customer choose to use the old adapters in their possession, the letter stresses and reiterates the ''Precautions and Warnings'' applic |
| Quantity | 155 bags |
| Distribution | Nationwide, including KS, OH, MD, FL, TX, CA, KY, MA, VA, WA, IL, AR and ME, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943882 | ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM Radiometer America, Inc., Mar 10, 1995 |