Recall Z-1133-2010 ยท CGA Glucose Oxidase, Glucose
Abbott Point of Care Inc.
Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, ca
| Date | Mar 15, 2010 (initiated Nov 6, 2009) |
| Status | Terminated |
| Reason | Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse. |
| Root cause | Component design/selection |
| Action | An "Urgent Recall Notice" dated October 2009 was sent to customers. The notice described the product, problem and action to be taken by the customers. The customers are requested to remove the printers from use, if they have a Martel printer with the specified serial numbers, that do not have a battery door for access to the rechargeable battery pack. The customers are ask to turn in to Abbott Point of Care or a designated repair facility, all affected Martel printers for battery pack replacement. Abbott will return the Martel printers to your facility at no charge. The customers are ask to |
| Quantity | 6432 printers (1208 have already been returned and repaired or scrapped) |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-Stat Corp., Oct 5, 2000 |