ModerateClass IITerminated

FDA Devices recall · Reported June 27, 2012

VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist yo

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 27, 2012. Severity: Moderate. Recall number: Z-1854-2012.

Q: Where was the recalled product distributed?

Distribution: US Nationwide Distribution.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently …

Recall #: Z-1854-2012
Affected scope: 1,167 units total
Initiated: February 6, 2012

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Accumetrics Inc recalled VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a… - a moderate-severity action.

VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a… was recalled by Accumetrics Inc in June 27, 2012. Reason: The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically t…. Check the official notice for the remedy. Verify recall #Z-1854-2012 with the FDA Devices before acting.

The recall

Accumetrics Inc issued this moderate-severity FDA Devices recall-The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically t….

Moderate
severity level: 1K units
affected scope: Class II
classification: June 27, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1854-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.

Reason for recall

The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1854-2012
Date reported	June 27, 2012
Date initiated	February 6, 2012
Recalling firm	Accumetrics Inc
Firm location	San Diego, CA
Affected scope	1,167 units total
Distribution	US Nationwide Distribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

1,167 units total units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1854-2012) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 27, 2012. Severity: Moderate. Recall number: Z-1854-2012.

Where was the recalled product distributed? ▼

Distribution: US Nationwide Distribution.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Big Cat Human Powered Vehicles Recalls Bi… 2012-06-27 Samuel Lawrence Furniture Recalls Sleigh … 2012-06-27 Alltrade Tools Recalls Kawasaki Cordless … 2012-06-27 LifeGas OXYGEN COMPRESSED UN1072 USP, D… 2012-06-27

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V… 2012-06-27 NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 … 2012-06-27 NIDEK Medical MARK5 NUVO 8 STD, 115 V~60H… 2012-06-27 NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~5… 2012-06-27

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported June 27, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026