Recall Z-1140-2022 ยท CIC Cresolphthalein Complexone, Calcium
MEDLINE INDUSTRIES, LP - Northfield
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
| Date | Oct 22, 2021 |
| Status | Terminated |
| Reason | Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to |
| Root cause | Process control |
| Action | Medline contacted affected consignee via telephone on 10/22/2021 and confirmed that the product had been destroyed. |
| Quantity | 6 boxes |
| Distribution | US Distribution to North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060205 | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER Horiba Abx, Jul 21, 2006 |