BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challen…

Recall #: Z-0807-2022
Affected scope: 724 Calibrator sets (U.S.)
Initiated: February 8, 2022

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

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Bio-Rad Laboratories, Inc. recalled BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL - a moderate-severity action.

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL was recalled by Bio-Rad Laboratories, Inc. in March 23, 2022. Reason: Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syp…. Check the official notice for the remedy. Verify recall #Z-0807-2022 with the FDA Devices before acting.

The recall

Bio-Rad Laboratories, Inc. issued this moderate-severity FDA Devices recall-Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syp….

Moderate
severity level: Class II
classification: March 23, 2022
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0807-2022 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

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Reason for recall

Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications

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	Ongoing
Recall number	Z-0807-2022
Date reported	March 23, 2022
Date initiated	February 8, 2022
Recalling firm	Bio-Rad Laboratories, Inc.
Firm location	Redmond, WA
Affected scope	724 Calibrator sets (U.S.)
Distribution	Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, W…

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

What to do with this recall

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

Check the recall number (Z-0807-2022) 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? ▼

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL. Recalled by Bio-Rad Laboratories, Inc.. Units affected: 724 Calibrator sets (U.S.).

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 23, 2022. Severity: Moderate. Recall number: Z-0807-2022.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates..

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

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Similar severity · nearest report date

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

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This recall: FDA Devices, reported March 23, 2022. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026