Recall Z-2270-2012 ยท JQP Calculator/Data Processing Module, For Clinical Use
Sunquest Information Systems, Inc.
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
| Date | Aug 24, 2012 (initiated Dec 5, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information. |
| Root cause | Software design |
| Action | Sunquest sent a recall letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your reply to this email message serves as verification you have received, read, understood and/or followed instructions outlined in the attached Product Safety Notification. Your reply assists Sunquest Information Systems to satisfy our obligation to Regulatory Agencies. Please note in your email reply if your site will not be requesting the software correction. If your site plans to request the software correction |
| Quantity | 127 sites |
| Distribution | Worldwide Distribution -- USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.