Recall Z-2238-2014 · JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
| Date | Aug 15, 2014 (initiated Jul 15, 2014) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal inv |
| Root cause | Material/Component Contamination |
| Action | Siemens sent an Urgent Medical Device Recall letter dated July 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the Customer: 1. Immediately discontinue use and discard all inventory of Chemistry Wash lot RD41041. If this lot was never in use on the instrument, no further action is needed. If this lot has been in use, continue with steps 2 through 5. 2. Place an alternate lot of Chemistry Wash on the Dimension system. 3. Prime the new bottle of Chemistry Wash 30 times. 4. Recalibra |
| Quantity | 3200 |
| Distribution | USA (nationwide) Distribution and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963498 | FERR FLEX REAGENT CARTRIDGE Dade Chemistry Systems, Inc., Jan 24, 1997 |