ModerateClass IITerminated

FDA Devices recall · Reported October 26, 2016

CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. antigen

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0128-2017.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution to CA, MN, OH and TX..

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.

CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity

Recall #: Z-0128-2017
Affected scope: 14 units
Initiated: September 21, 2016

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

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Becton, Dickinson and Company, Bd Biosciences recalled CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an… - a moderate-severity action.

CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an… was recalled by Becton, Dickinson and Company, Bd Biosciences in October 26, 2016. Reason: CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity. Check the official notice for the remedy. Verify recall #Z-0128-2017 with the FDA Devices before acting.

The recall

Becton, Dickinson and Company, Bd Biosciences issued this moderate-severity FDA Devices recall-CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity.

Moderate
severity level: 14 units
affected scope: Class II
classification: October 26, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0128-2017 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

CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. antigen

Reason for recall

CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity

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-0128-2017
Date reported	October 26, 2016
Date initiated	September 21, 2016
Recalling firm	Becton, Dickinson and Company, Bd Biosciences
Firm location	San Jose, CA
Affected scope	14 units
Distribution	Nationwide Distribution to CA, MN, OH and TX.

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

Scale of Impact

14 units 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-0128-2017) 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? ▼

CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0128-2017.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution to CA, MN, OH and TX..

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

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This recall: FDA Devices, reported October 26, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026