Device recall: ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
Class II FDA enforcement event 96752. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Mckesson Medical-Surgical Inc. Corporate Office started this device recall on 24 Apr 2025. The firm address in the FDA record is in Richmond, VA. FDA put the recall in Class II. FDA event 96752 has 32 product records. The first FDA enforcement report date is 4 Jun 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
32 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1824-2025 | ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1825-2025 | ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES. | 100 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1826-2025 | ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST. | 50 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1827-2025 | HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE. | 4 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1828-2025 | BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA. | 100 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1829-2025 | BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA. | 200 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1830-2025 | ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT. | 8 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1831-2025 | ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT. | 5 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1832-2025 | ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT. | 10 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1833-2025 | ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT. | 300 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1834-2025 | ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3. | 3 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1835-2025 | ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT. | 600 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1836-2025 | ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1837-2025 | ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT. | 60 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1838-2025 | HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1839-2025 | HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1840-2025 | ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1841-2025 | ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1842-2025 | ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT. | 4 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1843-2025 | ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1844-2025 | ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT. | 2 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1845-2025 | ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1846-2025 | ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE. | 25 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1847-2025 | ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT. | 400 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1848-2025 | ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1849-2025 | ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1850-2025 | ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1851-2025 | ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1852-2025 | ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT. | 2 units | Class II | Ongoing | 4 Jun 2025 |
| Z-1853-2025 | ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1854-2025 | SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
| Z-1855-2025 | HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT. | 1 unit | Class II | Ongoing | 4 Jun 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 32Median of the firm: 3
- Events of the firm on the register
- 15
Other events of the firm
Mckesson Medical-Surgical Inc. Corporate Office: all 15 events
Official channels
- FDA enforcement report Z-1824-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 96752. https://recallregister.com/fda/ii/96752/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- What quantity of product is in FDA event 96752?
- The event has 32 product records. The first record gives this quantity:
1 unit
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.