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.
This recall has been terminated (originally issued August 3, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- June 9, 2005
- Posted
- August 3, 2006
- Terminated
- February 24, 2012
- Recall Number
- Z-1320-06
- Quantity
- 155 bags
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide, including KS, OH, MD, FL, TX, CA, KY, MA, VA, WA, IL, AR and ME, and Canada.
Lot / Code Info
Part #906-018 lot 041643 to lot 045124
Root Cause
Other
Action Taken
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'' applicable for use of the ABL5 should air bubbles be observed in the measuring chamber by the user/operator.